EXTON, PA — Lungpacer Medical Inc. is commercializing an FDA-approved diaphragm stimulation system at U.S. hospitals to help critically ill patients discontinue mechanical ventilation, positioning its technology to address complications associated with prolonged dependence on breathing machines.
The AeroPace System, approved by the Food and Drug Administration in December 2024, uses a temporary catheter inserted into a vein to stimulate the phrenic nerves and activate the diaphragm.
The treatment is designed to strengthen and recondition the muscle after mechanical ventilation, which can leave patients unable to breathe independently. Prolonged ventilator use increases the risk of complications, tracheostomy and death.
Lungpacer described AeroPace as the first FDA-approved diaphragm neurostimulation therapy for patients receiving mechanical ventilation.
The technology has been nominated for the 2026 Prix Galien USA Award for Best Medical Technology. Winners will be recognized at an October ceremony marking the awards program’s 20th anniversary.
AeroPace originated with Simon Fraser University neuroscientist Andy Hoffer, who developed the concept after his mother was hospitalized with pneumonia and could not be removed from a ventilator in 2006.
Hoffer filed his first patent shortly after her death, and Simon Fraser University helped establish Lungpacer in 2009. Steven Reynolds, a critical care physician and university professor, contributed to early preclinical and first-in-human research.
Chief Executive Officer Doug Evans joined the company in 2014 after previously leading the sale of medical device manufacturer Kensey Nash. His son had died following a battle with leukemia that included prolonged mechanical ventilation.
“What began at two bedsides, Dr. Hoffer’s mother’s and my son’s, and grew through the pioneering work of Simon Fraser University and our team at Lungpacer, is now transforming lives in ICUs across the country,” Evans stated.
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